U.S. patent application number 15/664983 was filed with the patent office on 2017-11-16 for multiple clip deployment magazine.
The applicant listed for this patent is BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to John A. GRIEGO.
Application Number | 20170325822 15/664983 |
Document ID | / |
Family ID | 36215663 |
Filed Date | 2017-11-16 |
United States Patent
Application |
20170325822 |
Kind Code |
A1 |
GRIEGO; John A. |
November 16, 2017 |
Multiple Clip Deployment Magazine
Abstract
An apparatus for deployment of multiple hemostatic clips,
comprises a shaft connected to a handle and a control linkage
operatively connected to the handle in combination with a magazine
disposed at a distal end of the shaft, the magazine containing a
plurality of clips arranged in a chain rotatable within the
magazine, wherein a proximal-most one of the clips is coupled to
the control linkage, a distal portion of the magazine being
contoured to permit opening of a distal-most one of the clips
during a distal stroke of the control linkage, and to assist
closing and locking of the distal-most clip during a proximal
stroke of the control linkage, the magazine including an expanded
chamber sized to allow opening in any rotational orientation of a
next clip located immediately proximal to the distal-most clip to a
degree sufficient to disengage the distal-most clip. A method for
deploying multiple hemostatic clips, comprises positioning a distal
end of a magazine containing a clip chain over selected target
tissue and actuating a control link of the magazine in a distal
stroke to open and distally translate a distal-most clip of the
clip chain in combination with orienting the open distal-most clip
in a desired orientation to grasp the target tissue and actuating
the control link in a proximal stroke to close and lock the
distal-most clip over the target tissue. The control link is
further actuated in the proximal stroke to move a next clip
immediately proximal to the distal-most clip into an expanded
portion of the magazine sized to allow the next clip to open to a
degree sufficient to release the distal-most clip regardless of a
circumferential orientation of the next clip.
Inventors: |
GRIEGO; John A.; (Murrieta,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BOSTON SCIENTIFIC SCIMED, INC. |
Maple Grove |
MN |
US |
|
|
Family ID: |
36215663 |
Appl. No.: |
15/664983 |
Filed: |
July 31, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14701157 |
Apr 30, 2015 |
9763669 |
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15664983 |
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12543928 |
Aug 19, 2009 |
9044239 |
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14701157 |
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11032973 |
Jan 11, 2005 |
8080021 |
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12543928 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1285 20130101;
A61B 2017/0488 20130101; A61B 17/068 20130101; A61B 17/083
20130101; A61B 17/122 20130101; Y10T 29/53491 20150115; A61B
17/1227 20130101; A61B 2017/2937 20130101 |
International
Class: |
A61B 17/128 20060101
A61B017/128; A61B 17/122 20060101 A61B017/122 |
Claims
1-31. (canceled)
32. A multi-clip magazine, comprising: a clip chain comprising a
distal-most hemostatic clip and one or more additional hemostatic
clips arranged in a chain, each of the distal-most clip and the
additional clips comprising two clip arms biased toward an open
configuration; and an elongated shell extending along a
longitudinal axis from a proximal end to a distal end comprising a
central lumen extending along the longitudinal axis, the central
lumen comprising: a distal portion having a clip deployment opening
and surface features adapted to prevent passing of a next clip
immediately proximal to the distal-most clip before the distal-most
clip has been released from the clip chain, a proximal portion
having a cross-sectional diameter sized and shaped to push the arms
of each of the additional clips toward each other such that the
arms clamp over a proximal portion of an immediately distal clip in
the clip chain, and an expanded portion between the distal and
proximal portions, the expanded portion defining a chamber
expanding radially outward from the longitudinal axis than the
distal and proximal portions to permit the next clip to open and
release the distal-most clip.
33. The multi-clip magazine of claim 32, wherein the distal-most
clip is releasable from the clip chain regardless of a rotational
orientation of the next clip.
34. The multi-clip magazine of claim 32, wherein the expanded
portion is symmetrical with respect to the longitudinal axis.
35. The multi-clip magazine of claim 32, wherein the expanded
portion extends 360 degrees around a circumferences of the central
lumen.
36. The multi-clip magazine of claim 32, wherein the central lumen
is sized and shaped to allow free rotation of the clip chain about
the longitudinal axis.
37. The multi-clip magazine of claim 32, wherein the distal portion
is further adapted to lock the distal-most clip by positioning a
locking ring around the distal-most clip when it is released.
38. The multi-clip magazine of claim 37, wherein the distal portion
comprises an anti-pull back tab configured to hold the locking ring
when the distal-most clip extend out of the clip deployment
opening, and to subsequently position the locking ring around the
distal-most clip when the distal-most clip is retracted
proximally.
39. The multi-clip magazine of claim 32, wherein the proximal
portion is adapted to receive a control link operatively
connectable to the clip chain.
40. The multi-clip magazine of claim 32, wherein the surface
features of the distal portion comprise a reduced cross-section
portion.
41. The multi-clip magazine of claim 32, wherein the reduced
cross-section portion comprises a protrusion in an interior surface
of the central lumen extending toward the longitudinal axis.
42. The multi-clip magazine of claim 32, wherein the elongated
shell is adapted for insertion into a patient through an
endoscope.
43. The multi-clip magazine of claim 32, wherein the elongated
shell is substantially cylindrical.
Description
PRIORITY CLAIM
[0001] The present application is a Continuation of pending U.S.
patent application Ser. No. 14/701,157 filed on Apr. 30, 2015;
which is a Continuation of U.S. patent application Ser. No.
12/543,928 filed on Aug. 19, 2009 (now U.S. Pat. No. 9,044,239);
which is a Continuation of U.S. patent application Ser. No.
11/032,973 filed on Jan. 11, 2005 entitled "Multiple Clip
Deployment Magazine" (now U.S. Pat. No. 8,080,021). The entire
disclosure of the above patents/applications is expressly
incorporated herein by reference.
BACKGROUND
[0002] Endoscopic procedures to treat abnormal pathologies of the
gastro-intestinal ("GI") canal, of the biliary tree, of the
vascular system and of various other body lumens are becoming
increasingly common. An endoscope is basically a hollow tube placed
at a desired location within the body to facilitate access to the
relevant body ducts and lumens, etc. The endoscope itself cannot
carry out many of the required procedures. To that end, the
endoscope is fitted with a lumen, or internal channel, which
permits the user to insert various medical devices therethrough to
the location that requires treatment. Once the distal end of the
inserted device has reached the tissue to be treated, it can be
manipulated using controls which remain outside the body.
[0003] An hemostatic clipping tool is one of the devices which may
be inserted through an endoscope so that treatment may be carried
out. Hemostatic clips are deployed from the clipping tool and are
used to stop internal bleeding by clamping together the edges of a
wound. The clipping tool complete with clips attached to its distal
end is inserted through the endoscope to the location of the
bleeding. A clip is then remotely manipulated into position over
the site of bleeding, clamped over the wound and detached from the
tool. After a number of clips sufficient to stop the bleeding has
been deployed, the tool is withdrawn from the patient's body
through the endoscope. The size and shape of the clips and of the
clipping tool are limited by the inner diameter of the endoscope's
lumen, thus placing constraints on the design of the clip
positioning and release mechanisms.
[0004] One challenge facing the endoscope operator is to properly
position the hemostatic clips over the wound, so that closing the
clips over the tissue will be effective in stopping the bleeding.
If a clip is deployed improperly, additional clips may be required
to stop the bleeding extending the time required for and the
complexity of the procedure and leaving additional medical devices
within the patient. It is thus beneficial if the clipping tool
allows the user to orient the clips as required during deployment.
It is also important for the device operator to be certain of the
status of the clip during the deployment operation. For example,
before withdrawing the tool from the endoscope, the operator should
have positive indication that a clip has fully deployed, and has
been released from the tool. At the same time the design of the
tool should ensure that clips are fully released after they have
been closed over the tissue.
SUMMARY OF THE INVENTION
[0005] In one aspect, the present invention is directed to an
apparatus for deployment of multiple hemostatic clips, comprising a
shaft connected to a handle and a control linkage operatively
connected to the handle in combination with a magazine disposed at
a distal end of the shaft, the magazine containing a plurality of
clips arranged in a chain rotatable within the magazine, wherein a
proximal-most one of the clips is coupled to the control linkage. A
distal portion of the magazine is contoured to permit opening of a
distal-most one of the clips during a distal stroke of the control
linkage and to assist closing and locking of the distal-most clip
during a proximal stroke of the control linkage. The magazine
includes an expanded chamber sized to allow opening in any
rotational orientation of a next clip located immediately proximal
to the distal-most clip to a degree sufficient to disengage the
distal-most clip from the clip chain.
[0006] The present invention is further directed to a method for
deploying multiple hemostatic clips, comprising positioning a
distal end of a magazine containing a clip chain over selected
target tissue and actuating a control link of the magazine in a
distal stroke to open and distally translate a distal-most clip of
the clip chain in combination with orienting the open distal-most
clip in a desired orientation to grasp the target tissue and
actuating the control link in a proximal stroke to close and lock
the distal-most clip over the target tissue. The control link is
further actuated in the proximal stroke to move a next clip
immediately proximal to the distal-most clip into an expanded
portion of the magazine sized to allow the next clip to open to a
degree sufficient to release the distal-most clip from the clip
chain regardless of a circumferential orientation of the next clip
and the distal-most clip is released by partially opening the next
clip.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a schematic side view of a clipping device
according to an embodiment of the present invention with FIG. 1A
showing a detail view of an exemplary clip assembly;
[0008] FIG. 2 is a schematic side view of the embodiment shown in
FIG. 1, with a outer sheath;
[0009] FIG. 3 is a cut away side view of the shaft section
according to an embodiment of the present invention;
[0010] FIG. 4 is a cross sectional view of the shaft section shown
in FIG. 3;
[0011] FIG. 5 is a detail view of the distal end of the control
wire according to an embodiment of the present invention;
[0012] FIG. 6 is a perspective view of an outer sheath according to
an embodiment of the present invention;
[0013] FIG. 7 is an cross sectional exploded view of the handle of
the outer sheath shown in FIG. 6;
[0014] FIG. 8 is a perspective view of an outer sheath lock
according to an embodiment of the present invention;
[0015] FIG. 9 is a cross sectional side view of a distal end of a
clipping device according to an embodiment of the present
invention;
[0016] FIG. 10 is a cross sectional top view of a distal end of the
clipping device shown in FIG. 9;
[0017] FIG. 11 is a perspective view of the distal end of the
clipping device shown in FIG. 9;
[0018] FIG. 12 is a top view of the clip arms according to an
embodiment of the present invention;
[0019] FIG. 13 is a perspective view of the clip arms shown in FIG.
12, according to an embodiment of the present invention;
[0020] FIG. 14 is a perspective view of a capsule according to an
embodiment of the present invention;
[0021] FIG. 15 is a cross sectional side view of the of the capsule
shown in FIG. 14;
[0022] FIG. 16 is a top view of the distal end of a clipping device
according to an embodiment of the present invention;
[0023] FIG. 17 is a side view of the distal end shown in FIG.
16;
[0024] FIG. 18 is a perspective view of a clip arm according to an
embodiment of the present invention;
[0025] FIG. 19 is a side view of the clip arm shown in FIG. 18;
[0026] FIG. 20 is a top view of the clip arm shown in FIG. 18;
[0027] FIG. 21 is a perspective view of a bushing according to an
embodiment of the present invention;
[0028] FIG. 22 is a cross sectional side view of the bushing shown
in FIG. 21;
[0029] FIG. 23 is a perspective view of a wire stop according to an
embodiment of the present invention;
[0030] FIG. 24 is a schematic side view of a clip assembly detached
from a bushing, according to an embodiment of the present
invention;
[0031] FIG. 25 is a side view of a tension member according to an
embodiment of the present invention;
[0032] FIG. 26 is a top view of the tension member shown in FIG.
25;
[0033] FIG. 27 is a top view of a yoke according to an embodiment
of the present invention;
[0034] FIG. 28 is a perspective view of the yoke shown in FIG.
27;
[0035] FIG. 29 is a top view of a yoke with a control wire
according to an embodiment of the present invention;
[0036] FIG. 30 shows a detail of a connection between a control
link and a clip chain according to an embodiment of the
invention;
[0037] FIG. 31 shows a perspective view of an individual hemostatic
clip of a clip chain according to an embodiment of the
invention;
[0038] FIG. 32 shows a side elevation view of a clip chain
according to an embodiment of the invention;
[0039] FIG. 33 shows a perspective view of a second embodiment of a
clip for a clip chain according to the invention;
[0040] FIG. 34 shows a perspective view of a third embodiment of a
clip for a clip chain according to the invention;
[0041] FIG. 35 shows a perspective view of the clip chain shown in
FIG. 32;
[0042] FIG. 36 shows a perspective view of a clip magazine
according to an embodiment of the invention;
[0043] FIG. 37 shows a distal end detail of the clip magazine shown
in FIG. 36;
[0044] FIG. 38 shows a cut away perspective view of a clip chain
loaded in a clip magazine according to an embodiment of the
invention;
[0045] FIG. 39 shows the clip chain of FIG. 38 being pushed out of
the clip magazine;
[0046] FIG. 40 shows the clip chain of FIG. 38 yet further out of
the clip magazine with one clip deployed;
[0047] FIG. 41 shows a distal end detail of the clip magazine shown
in FIG. 39;
[0048] FIG. 42 shows the clip chain of FIG. 38 with a clip deployed
and released from the clip chain;
[0049] FIG. 43 is a schematic diagram showing a detail of the
magazine an clips according to an embodiment of the present
invention;
[0050] FIG. 44 is a cut-away diagram showing two clips in the
magazine in a pre-deployment configuration;
[0051] FIG. 45 is a cut-away diagram showing one of the clips shown
in FIG. 44 with open clip arms;
[0052] FIG. 46 is a cut-away diagram showing one of the clips of
FIG. 44 being locked in the closed configuration;
[0053] FIG. 47 is a cut-away diagram showing one of the clips of
FIG. 44 being disconnected from the other clip; and
[0054] FIG. 48 is a cut-away diagram showing one of the clips of
FIG. 44 deployed from the magazine.
DETAILED DESCRIPTION
[0055] Hemostatic clips are used routinely to stop bleeding from
openings created during surgery as well as wounds resulting from
other trauma to tissues. In the simplest form, these clips grasp
the tissue surrounding a wound and bring the wound's edges
together, to allow the natural scarring process to heal the wound.
Endoscopic hemostatic clips are used to stop internal bleeding due
resulting from surgical procedures and/or tissue damage from
disease, etc. Specialized endoscopic hemostatic clipping devices
are used to bring the clips to the desired location within a
patient's body and to position and deploy the clip at the
appropriate place on the tissue. The clipping device is then
withdrawn, leaving the clip within the patient. Such hemostatic
clipping devices are described in U.S. patent application Ser. No.
10/647,512, filed on Sep. 30, 2003, and Provisional U.S. patent
application Ser. No. 60/518,167 which are hereby incorporated
herein by reference in their entirety.
[0056] Endoscopic hemostatic clipping devices are designed to reach
affected tissues deep within a patient's body, such as within the
GI tract, the pulmonary system, the vascular system or within other
lumens and ducts. During the procedures to treat those areas, an
endoscope is generally used to provide access to and visualization
of the tissue which is to be treated. The clipping device may, for
example, be introduced through a working lumen of the endoscope.
The design and construction of such a "through the scope"
endoscopic hemostatic clipping device presents several challenges.
The endoscopic clipping device has to be sufficiently small to fit
in the lumen of an endoscope and, at the same time, must be
designed to provide for the positive placement and actuation of the
hemostatic clip. Feedback to the operator is preferably also
provided so that the operator will not be confused as to whether
the hemostatic clip has been properly locked in place on the tissue
and released from the device before the device itself is withdrawn
through the endoscope.
[0057] FIG. 1 shows a side elevation view of a through the scope
hemostatic clipping device according to an exemplary embodiment of
the present invention. This device is a hand operated tool that is
used to insert a hemostatic clip through an endoscope lumen,
position the clip over a wound, clamp it and deploy it over the
affected tissue. The tool is further designed to release the
hemostatic clip once it has been clamped in place, and to be
withdrawn through the endoscope. To more clearly explain the
operation and construction of the exemplary device, it may be
divided into three principal components. As shown, the hemostatic
clipping device 100 comprises a handle assembly 102, a shaft
section 104, and a clip assembly 106. The clip assembly 106 is
shown more clearly in FIG. 1A.
[0058] Handle assembly 102 forms the component that supplies a
mechanical actuation force to deploy and clamp the clip. In this
embodiment, the device is hand operated (i.e., the user's hands
provide the force required to carry out all the functions related
to the hemostatic clip). The handle assembly 102 may be constructed
in a manner similar to conventional handle assemblies of the type
generally employed in endoscopic biopsy devices or in similar
applications. The handle assembly 102 allows the user to move a
control wire 118 or other force transmission member, which extends
through the shaft section 104 to the clip assembly 106 at a distal
end of the device 100. The handle assembly 102 comprises a handle
body 108 which can be grasped by the user to stabilize the device
and apply a force to it. A sliding spool 110 is connected to
control wire 118, so that the user can easily pull or push said
wire 106 as desired.
[0059] As shown in FIGS. 1 and 2, a sliding spool 110 is mounted on
the handle body 108 so that it can slide along a slot 116, which
maintains its position within the handle assembly 102. Because the
sliding spool 110 is connected to the control wire 118, the user
may manipulate the control wire 118 by grasping the handle body 108
and moving the sliding spool 110 along the slot 116. A return
spring 112 may be provided within the handle body 108 to bias the
sliding spool 110, and thus the control wire 118 toward a desired
position. In the present embodiment, the sliding spool 110 is
biased to the proximal position. The handle assembly 102 may also
include a connection portion 114, which receives the control wire
118 and attaches the shaft section 104 to the handle assembly
102.
[0060] The shaft section 104 mechanically connects the handle
assembly 102 to the clip assembly 106 and, together with the clip
assembly 106, is designed to be inserted into a lumen of an
endoscope. As shown in FIGS. 3 and 4, the shaft section 104
comprises an outer flexible coil 130 which is designed to transmit
a torque from the proximal end to the distal end of the device 100
and to provide structural strength to the shaft section 104. The
coil 130 may be a conventional coil used in biopsy devices and may,
for example, comprise a single, coiled wire. The coiled wire may
have a round, square or a rectangular cross section, and may be
made of a biocompatible material such as, for example, stainless
steel. Additional protective and low friction outer layers may be
included on the shaft section 104, according to known methods of
construction.
[0061] The control wire 118 transmits mechanical force applied to
the handle 102 to the clip assembly 106. The control wire 118 has a
proximal end which is attached to a movable part of the handle 102,
such as the sliding spool 110, using known methods. Stainless steel
or other high yield biocompatible materials may be used to
manufacture the control wire 118, so that the structural integrity
of the assembly is maintained. It is also important to prevent
stretching of the control wire 118 when under tension since, if the
wire stretches, the handle 102 will have to travel a greater
distance to carry out a desired operation. As shown in FIG. 5, the
distal end of the control wire 118 ends in a ball 140 which is used
to connect the control wire 118 to the appropriate elements of the
clip assembly 106, as will be described below. In this embodiment,
the diameter of the control wire 118 is substantially constant from
a proximal end thereof to a proximal end of a distal tapered
section 144. The ball 140 may have a diameter which is greater than
the diameter of the control wire 118, to facilitate attachment to a
yoke 204. The control wire 118 may extend the length of the device
100, from the yoke 204 to the sliding spool 110, and may be
designed to slide longitudinally along the device 100. It may be
made, for example, of stainless steel or other biocompatible
metal.
[0062] The control wire 118 may also include a reduced diameter
section 142 designed to fail when a predetermined tension is
applied thereto through the handle assembly 102.
[0063] The tapered section 144 may be used to transition between
the main body of the control wire 118 and the reduced diameter
section 142, without steps or other discontinuities which may
concentrate stress and make the fracture point more unpredictable.
As will be described in greater detail below, one purpose of the
reduced diameter section 142 is to facilitate the release of a
hemostatic clip from the hemostatic clipping device 100 once the
clip has been properly deployed. It will be apparent to those of
skill in the art that the location of the reduced diameter section
142 the along control wire 118 may be varied to take into account
specific requirements of the device 100.
[0064] An inner sheath 132 may be used in the construction of the
shaft section 104, as shown in FIGS. 3 and 4. The inner sheath 132
provides a low friction bearing surface disposed between the outer
diameter of the control wire 118, and the inner diameter of the
shaft section 104. The inner sheath 132 may be formed of a low
friction material such as, for example, Teflon.TM., HDPE or
Polypropylene. In one exemplary embodiment, the inner sheath 132 is
slidable within the shaft section 104, and the control wire 118 is
slidable within the inner sheath 132 forming a low friction system
of multiple bearing surfaces. To further reduce friction, a
bio-compatible lubricant may be applied to the inner and outer
surfaces of the inner sheath 132, along the length of the shaft
section 104. For example, silicone lubricants may be used for this
purpose.
[0065] A slidable over-sheath 150 may be included in the design of
the shaft section 104, as shown in FIGS. 1 and 2. The over-sheath
150 is designed to protect the inner lumen of the endoscope from
the metal clip assembly 106 and from the metal coil 130 while the
hemostatic clipping device 100 passes through the endoscope's
lumen. After the clipping device 100 and, more specifically, after
the clip assembly 106 has passed through the endoscope, the
over-sheath 150 may be withdrawn to expose the distal portion of
the clipping device 100. The over-sheath 150 may be formed, for
example, as a single lumen plastic extrusion element slidable over
the distal portions of the clipping device 100 to selectively cover
and uncover the clip assembly 106. In one embodiment, the
over-sheath 150 is formed of a low friction polymer such as, for
example, Teflon.TM., HDPE, Polypropylene, or similar materials.
[0066] The over-sheath 150 may include a grip portion 152 and an
elongated body 154. The grip portion 152 is designed as a handle
making it easier for the user to slide the over-sheath 150 over the
shaft of the clipping device 100. In one exemplary embodiment, the
grip portion 152 is made of a rubber-like material to provide a
good gripping surface for the user. For example, an injection
moldable polymer such as TPE may be used to construct the grip
portion 152. The elongated body 154 may be formed as a
substantially cylindrical shell surrounding the shaft of the
clipping device 100. The elongated body 154 may be attached to the
grip portion 152 using conventional methods as would be understood
by those skilled in the art.
[0067] As shown in FIGS. 6 and 7, an exemplary grip portion 152
comprises a central hollow channel 160 that may be used to receive
the shaft of the clipping device 100. The central hollow channel
160 is aligned with the elongated body 154 to provide a continuous
channel containing the shaft of the clipping device 100. The
material of the grip portion 152 may have a high coefficient of
friction, so that an interference fit is possible between the
central hollow channel 160 and the shaft of the clipping device 100
without the use of adhesives or mechanical fastening devices. In
one embodiment, friction bosses 158 may be provided on an inner
diameter of the hollow channel 160 to provide additional friction
between the shaft of the clipping device 100 and the over-sheath
150 assembly. The friction bosses 158 may be formed, for example,
as protrusions extending from the inner diameter of the over-sheath
150 and may have a variety of stubby or elongated shapes. The
amount of friction between these two components may be balanced so
that no unwanted relative movement takes place while, at the same
time, making it relatively easy for the user to slide the
over-sheath 150 proximally and distally when necessary.
[0068] A sheath stop 156 may be provided for the clipping device
100 to prevent the over-sheath 150 from sliding away from the
distal end while the clipping device 100 is inserted in the
endoscope. As shown in the exemplary embodiment of FIGS. 2 and 8,
the sheath stop 156 physically blocks the grip portion 152 from
sliding proximally to prevent the over-sheath 150 from being
withdrawn and exposing the clip assembly 106. The sheath stop 156
is designed to easily snap in place near the proximal end of the
shaft section 104 where it can be reached and manipulated by the
operator during the surgical procedure. Once the clip assembly 106
has been inserted in the endoscope and has reached the desired
location in the patient's body, the sheath stop 156 may be removed
from the shaft section 104 so that the user can move the grip
portion 152 proximally to uncover the clip assembly 106.
[0069] The connection between the sheath stop 156 and the shaft
section 104 may include, for example, pairs of opposing fingers
162, 164 that are designed to snap over the shaft section 104. The
fingers 162, 164 cooperate to securely and releasably hold the body
of the shaft section 104 therebetween. The fingers 162, 164
respectively comprise guide portions 170, 172; shaft channel
portions 166, 168; and blocking portions 174, 176. Insertion of the
sheath stop 156 on the elongated body 154 is accomplished by
pressing the body of the shaft section 104 between the guide
portions 170, 172, to spread the fingers 162, 164 and allow further
insertion of the shaft 104 between the fingers 162, 164. The guide
portions 170, 172 and the blocking portions 174, 176 are shaped so
that insertion of the shaft section 104 towards the channel
portions 166, 168 requires less effort than moving the shaft
section 104 in the opposite direction.
[0070] Once shaft section 104 has been placed within the channel
portions 166, 168, the fingers 162, 164 snap back to their
non-spread position and retain the shaft section 104 in place
therebetween. The shaft section 104 is removed by pulling the
sheath stop 156 away from the shaft section 104. Due to the shape
of the blocking portions 174, 176, removing the shaft section 104
requires the application of more force than does insertion
thereinto. Stops 180 may also be provided on the sheath stop 156 to
limit the movement of the shaft section 104 towards the grasping
portion 161 to prevent damage to the device that may be caused by
excessive spreading of the fingers 162, 164. The sheath stop 156
may be formed of a resilient material, such as a polymer, and may
be manufactured by injection molding.
[0071] The clip assembly 106 is disposed at the distal end of the
clipping device 100, and contains the mechanism that converts the
proximal and distal movement of the control wire 118 into the
actions necessary to deploy and release a hemostatic clip 90. FIGS.
9, 10 and 11 show, respectively, side, top and perspective views of
the distal end of the clipping device 100, including the clip
assembly 106 having clips in the folded configuration. This
configuration is used, for example, to ship the clipping device 100
and to insert the clipping device 100 through the lumen of an
endoscope. Some of the components of the clip assembly 106 include
a capsule 200 which provides a structural shell for the clip
assembly 106, the clip arms 208 which move between open and closed
positions, a bushing 202 attached to the distal end of the control
wire 118, and a yoke 204 adapted to connect the capsule 200 to the
control wire 118.
[0072] As depicted, the proximal end of the capsule 200 slides over
the distal end of the bushing 202. A locking arrangement between
these two components is provided by capsule tabs 212, which are
designed to lock into the bushing 202 so that mechanical integrity
is temporarily maintained between the capsule 200 and the bushing
202. Within the capsule 200 are contained a yoke 204 and a tension
member 206 which transmit forces applied by the control wire 118 to
the clip arms 208. The ball 140 formed at the distal end of the
control wire 118 is mated to a receiving socket 210 formed at the
proximal end of the yoke 204. A male C-section 214 extending from
the tension member 206 is received in a corresponding female
C-section 216 formed in the yoke 204, so that the two components
are releasably connected to one another, as will be described
below. The clip arms 208 in the closed configuration have a radius
section 300 which is partially contained within the capsule 200 to
prevent opening of the arms. Each of the clip arms 208 goes over
the tension member 206 and has a proximal end 222 which slips under
a yoke overhang 254, to further control movement of the arms
208.
[0073] FIGS. 12 and 13 show a top and a perspective view of one
exemplary embodiment of the clip assembly 106 in an open
configuration with the clip arms 208 in a fully open position. The
open configuration is obtained when the sliding spool 110 shown in
FIG. 1 is moved distally so that the ball 140 of the control wire
118 pushes the assembly containing the yoke 204 and the tension
member 206 forward, sliding within the capsule 200. As will be
described below, the distal ends of the clip arms 208 are biased
toward the open position and revert to this position whenever they
are not constrained by the capsule 200. In the exemplary
embodiment, a maximum opening of the clip arms 208 occurs when the
clip arms 208 ride over the folded distal folding tabs 220 which
extend from the distal end of the capsule 200, as shown in FIGS. 14
and 15. In this embodiment, the tabs 220 provide a cam surface, and
the clip arms 208 act as cam followers, being deflected by the tabs
220. In addition, the folding tabs 220 may also provide a distal
stop for the tension member 206, to retain it within the capsule
200. Thus, by moving the sliding spool 110 distally, the user opens
the clip arms 208 to prepare to grasp tissue therebetween.
[0074] When the sliding spool 110 is moved proximally by the user,
the assembly within the capsule 200 also moves proximally and the
clip arms 208 are withdrawn within the capsule 200. As the clip
arms 208 move proximally within the capsule 200, clip stop
shoulders (CSS) 222 contact a distal portion of the capsule 200,
for example, the folded tabs 220. This interaction of the CSS 222
with the capsule 200 provides to the user a first tactile feedback
in the form of increased resistance to movement of the sliding
spool 110. This feedback gives to the operator a positive
indication that further movement of the handle control will cause
the hemostatic clip 90 to be deployed from the clip assembly 106.
The operator may then decide whether the current position of the
clip 90 is acceptable or not. If the position is acceptable, the
operator can deploy the clip 90 by continuing to move the sliding
spool 110 with increased proximal pressure to cause the clip arms
208 to close on the tissue. If not, the operator can move the
sliding spool 110 distally to re-open the clip arms 208 and extend
them out of the capsule 200, reposition the clip 90, and repeat the
above steps to close the clip 90 at a more appropriate
location.
[0075] When the user determines that the clipping device 100 is
positioned correctly, the proximal pressure on the sliding spool
110 may be increased to continue deployment of the hemostatic clip
90 from the clip assembly 106. FIGS. 16 and 17 show respectively a
top and side view of the clipping device 100 in this condition. As
the proximal tension on sliding spool 110 is increased, the control
cable 118 pulls the yoke 204 proximally, away from the tension
member 206. The tension member 206 is firmly attached to the clip
arms 208 which are prevented from moving proximally by the
interaction of the CSS 222 with the folded tabs 220. If sufficient
pulling force is applied to the yoke 204, the male C section 214 of
the tension member 206 yields and loses integrity with the female C
section 216 of the yoke 204. This can occur because, in the
exemplary embodiment, the tension member 206 is formed of a
material with a lower yield strength than the material of the yoke
204.
[0076] The force required to break the tension member 206 away from
the yoke 204 may be tailored to achieve a desired feedback that can
be perceived by the user. The minimum force required to break the
tension member 206 free of the yoke 204 may be selected so that a
tactile feedback is felt by the user, to prevent premature
deployment of the hemostatic clip 90 while a maximum force may be
selected so that other components of the linkage between the
sliding spool 110 and the clip arms 208 do not fail before the male
C section 214 and the female C section 216 disconnect from one
another. In one exemplary embodiment, the tension force necessary
to disconnect the two components may be in the range of
approximately 4 lbf to about 12 lbf. This range may vary depending
on the size of the device and the specific application. To obtain
this force at the interface of the male and female C sections 214,
216 a larger force will be applied by the user at the sliding spool
110, since friction within the device may cause losses along the
long flexible shaft.
[0077] When the male C section 214 of tension member 206 yields,
several events take place within the exemplary device 100 nearly
simultaneously. More specifically, the yoke 204 is no longer
constrained from moving proximally by the CSS 222 abutting the
capsule 200. Thus the yoke 204 travels proximally until coming to
rest against a distal bushing shoulder 250. The tension member 206
is not affected by this movement since it is no longer connected to
the yoke 204. The proximal ends 252 of the clip arms 208 are
normally biased away from a center line of the device 100 and are
no longer constrained by the yoke overhangs 254. Accordingly, the
clip latches 302 are free to engage the latch windows 304 of the
capsule 200, thus maintaining the integrity of the capsule-clip
arms combination after deployment. Details of one exemplary
embodiment of the capsule 200 are shown in FIGS. 14, 15 and details
of the clip arms 208 are shown in FIGS. 18, 19 and 20.
[0078] As the yoke 204 moves proximally to abut against the bushing
202, the capsule tabs 306 are bent away from the centerline of the
capsule 200 by the cam surfaces of the yoke 204. As a result, the
capsule tabs 306 are no longer engaged to the corresponding bushing
undercuts 350, shown in the side and perspective views of the
bushing 202 depicted in FIGS. 21, 22. Since the capsule 200 and the
bushing 202 (which is securely connected to shaft section 104) are
no longer connected, the clip assembly 106 is prevented from being
released from the shaft section 104 only by its connection to the
ball 140 of the control wire 118.
[0079] A further result of moving the yoke 204 against the distal
bushing shoulder 250 of the bushing 202 is that the distal end of
the wire stop 360 (shown in FIGS. 12, 16) is placed near the
proximal bushing shoulder 364 (shown in FIG. 22). The flared
fingers 362 located at the distal end of the wire stop 360, better
shown in FIG. 23, are compressed as they pass through the central
ID of the bushing 202, but return to their normally biased open
position (shown in FIG. 23) after passing past the proximal bushing
shoulder 364. Further distal movement of the sliding spool 110 is
thus prevented since that movement would engage the fingers 362 of
the wire stop 360 with the proximal bushing shoulder 364. This
feature prevents the clip assembly 106 from being pushed away from
the bushing 202 before the ball 140 is separated from the control
wire 118, as will be described below.
[0080] The wire stop 360 comprises a tube with a first slotted and
flared end attached to the control wire 118 by conventional means.
As shown in FIG. 23, the slots impart flexibility to the device so
it can easily pass through the central lumen of the bushing 202.
Flared fingers 362 are formed by the slots, and engage the proximal
bushing shoulder 364. The wire stop 360 is made of a material that
is biocompatible and that has enough resilience so that the fingers
362 re-open after passage through the bushing 202. For example,
stainless steel may be used for this application.
[0081] One feature of the exemplary embodiment of the invention
described above is that the user receives both tactile and auditory
feedback as the clip assembly 106 is deployed and released. The
separation of the tension member 206 from the yoke 204 produces a
small clicking noise and a tactile feel that is perceptible while
holding the handle assembly 102. The change in axial position of
the sliding spool 110 is thus augmented by the changes in
resistance to its movement and by the clicking sound and feel
through the start and stop of the movement. As a result the user is
always aware of the status of the clip assembly 106, and the
inadvertent deployment of a hemostatic clip 90 in an incorrect
location is less likely. It will be apparent to those of skill in
the art that the order of male and female connectors in the device
may be reversed or changed without affecting the operation of the
device.
[0082] It may be beneficial for the user to be certain that the
clip assembly 106 has been deployed before the rest of the clipping
device 100 is removed from the endoscope. Injury to the tissue
being treated could result if the clipping device 100 is removed
from the operative site when the hemostatic clip 90 is only
partially deployed. Accordingly, a large tactile feedback may be
incorporated, to augment the auditory and tactile feedback stemming
from the separation of the yoke 204 from the tension member 206.
FIG. 24 depicts the condition where the clip assembly 106 separates
from the rest of the clipping device 100. According to the
described embodiment, this second user feedback is obtained by
designing the control wire 118 so that it will separate from the
end ball 140 when a predetermined tension is applied to it. In
other words, the ball 140 of the control wire 118 is mechanically
programmed to yield and separate from the body of the control wire
118 when a pre-set tension is applied thereto. The size of the
reduced diameter section 142 can be selected so that, when the user
continues to move the sliding spool 110 proximally as the
programmed yield tension is reached, the ball 140 detaches from the
tapered section 144 and provides a large tactile feedback to the
operator.
[0083] When the ball 140 detaches, the sliding spool 110 bottoms
out at the proximal end of the handle 108, such that a full stroke
of the handle assembly 102 is reached. The tension required to
cause the reduced diameter section 142 to yield and release the
ball 140 may vary over a range of values. However, for best results
the force should be greater than the tension force required for the
male C section member 214 to separate from the yoke 204. If this
condition is not satisfied, a situation may occur where the clip
assembly 106 is locked in place on the patient's tissue, but cannot
be released from the clipping device 100. It will be apparent that
this situation should be avoided. In one exemplary embodiment, the
tension force required to separate the ball 140 from the body of
the control wire 118 is in the range of between about 10 lbf and 20
lbf at the distal end of the control wire 118. As discussed above,
losses along the elongated flexible shaft may require the user to
apply a force substantially greater than this to the handle body
102.
[0084] Once the ball 140 has separated from the rest of the control
wire 118, the user can pull the rest of the clipping device 100
from the endoscope. As this is done, the yoke 204 is retained
within the capsule 200 by the spring and frictional forces of
various features of the capsule 200, such as the capsule tabs 306.
Prior to withdrawing the clipping device 100, the over-sheath 150
may be moved distally by the user over the entire remaining
portions of the shaft section 104 to prevent damage to the
endoscope as the clipping device 100 is withdrawn therethrough. The
sheath stop 156 may also be placed on the shaft section 104
proximally of the over-sheath grip 152 to prevent inadvertent
sliding of the over-sheath 150 from the distal end of the device
100.
[0085] A more detailed description of several components of the
clipping device 100 follows. The clip arms 208 are shown in detail
in FIGS. 18, 19 and 20; the tension member 206 is shown in side and
top views in FIGS. 25, 26; while top and side views of the yoke 204
are shown respectively in FIGS. 27 and 28. the clip arms 208 may be
formed of a biocompatible material such as Nitinol, Titanium or
stainless steel. Maximum spring properties may be obtained by using
materials such as 400 series stainless or 17-7 PH. As shown, a tear
drop keyway 400 is formed in the clip arm 208 to mate with a
corresponding tear drop key 402 formed on the tension member 206.
This feature maintains the relative positions of these two
components and of the yoke 204 substantially constant. The shape of
the keyways 400 may be varied. For example, the keyway 400 may be
oval or elliptical. Central portions of the clip arms 208 define a
spring section 404. When the proximal ends 252 of the clip arms 208
are under the yoke overhangs 254, the clip arms 208 are allowed to
pivot over the tension member 206, which in turn biases the distal
ends 252 towards the open configuration when no longer restrained
by the capsule 200. As a result, the proximal end 252 of each clip
arm 208 springs upward and engages the latch windows 304 in the
capsule 200.
[0086] the clip arms 208 also comprise a radius section 300 that
adds strength to the clip and reduces system friction. The radius
of the radius section 300 approximately matches the inner diameter
of the capsule 200 and has a smooth profile to avoid scratching the
inner surface of the capsule 200. A pre-load angle .alpha. is
defined between the radius section 300 and the spring section 404.
The pre-load angle .alpha. determines how much interference
(pre-load) exists between the two opposing clip arms 208 at their
distal ends when closed. The greater the pre-load angle .alpha.,
the greater the engaging force that is applied by the clip arms
208. However, this condition also causes the greatest system
friction when the hemostatic clip 90 is closed. The clip arms 208
also comprise interlocking teeth 408 disposed at their distal ends.
In the exemplary embodiment, the teeth 408 are identical so that
the arms may be interchangeable and will mesh smoothly with the set
facing them. The teeth 408 are disposed at a nose angle .beta.
which may be between approximately 90 and 135 degrees, but in other
applications may be greater or lesser than the described range.
[0087] One exemplary embodiment of the capsule 200 is shown in
detail in FIGS. 14 and 15 and comprises alignment keyways 500 that
are designed to mate with corresponding features on the bushing 202
to rotationally align the two components. In this embodiment, the
capsule tabs 306 may be bent towards the centerline of the capsule
200 to engage the bushing undercuts 350. The engagement maintains
the integrity between the capsule assembly 200 and the rest of the
clipping device 100 until the yoke is pulled into the distal
bushing shoulder. the capsule overhangs 502 provide added clamping
strength to the deployed clip arms 208. This is achieved by
reducing the length of the portion of each clip arm 208 that is not
supported by a portion of the capsule 200. This feature does not
affect the amount of tissue that may be captured by the clip arms
208 since the capsule overhangs 502 extend on a plane substantially
parallel to the plane of the clip arms 208.
[0088] Additional features of the capsule 200 include an assembly
aid port which may be used to assist in aligning the components of
the clip assembly 106. Bending aids 506 facilitate a smooth bend
when the distal folding tabs 220 are bent inward, as described
above. The bending aids 506, as shown, are holes aligned with the
folding line of the tabs 220, but may also include a crease, a
linear indentation, or other type of stress concentrator. The
capsule 200 may be formed from any of a variety of biocompatible
materials. For example, stainless steel, Titanium or Nitinol or any
combination thereof may be used. High strength polymers like
PEEK.TM. or Ultem.TM. may also be used to form the capsule 200,
with a heat set treatment being used to adjust positionable
elements.
[0089] FIGS. 25 and 26 depict additional details of the tension
member 206. As shown, tear drop keys 402 are designed to engage the
tear drop keyways 400 of the clip arms 208, as described above.
Clip follower planes 508 are shaped to form a fulcrum which allows
the clip arms 208 to rock between the open and closed
configurations. The tension member 206 comprises a distal stop face
510 which abuts the distal folding tabs 220 of the capsule 200 to
stop the distal motion of the capsule assembly 106. In general, all
surfaces and edges of the tension member 206 that are in contact
with the inner surfaces of the capsule 200 preferably have a radius
substantially similar to an inner radius of the capsule 200 to
provide a sliding fit therein. The tension member 206 may be formed
of a biocompatible polymer, monomer or thermoset. The type of
mechanism selected to release the tension member 206 from the yoke
204 may determine the type of material used since a release due to
fracture of the male C section 214 requires a relatively brittle
material while release due to yielding without fracture calls for a
softer material.
[0090] Additional details of the yoke 204 are shown in FIGS. 27-29.
When the control wire 118 is seated in the yoke 204, it is
desirable to ensure that it cannot inadvertently be removed from
the control wire slot 600. Accordingly, in the present embodiment
the ball cavity 602 has a diameter sufficiently large to allow the
ball 140 to pass therethrough while the wire cavity 604 is large
enough to allow the control wire 118 to pass therethrough, but not
large enough to allow the ball 140 pass therethrough. To assemble
the control wire 118 with the yoke 204 according to the exemplary
embodiment, the proximal end of wire 140 is inserted into the ball
cavity 602 until the ball bottoms out, and then the control wire
118 is rotated until it is seated in the control wire cavity 604,
thus constraining further movement of the ball 140. According to
the present embodiment, the yoke 204 may be made of a biocompatible
metal such as stainless steel or a high strength polymer such as
Ultem.TM..
[0091] According to embodiments of the present invention, the
clipping device 100 may be scaled to fit the requirements of
different surgical procedures. In one exemplary embodiment, the
clipping device 100 may be sized to fit through an endoscope having
a working channel diameter of approximately 0.110 inches. The
exemplary bushing may have a length of about 0.22 inches and an OD
of approximately 0.085 inches. The capsule may have a length of
about 0.5 inches, an OD of about 0.085 inches, and a wall thickness
of about 0.003 inches. When assembled, the rigid length of the
capsule 200 and the bushing 202 is approximately 0.625 inches. This
length is important because if it is too great, the assembly will
not pass through the bends of the flexible endoscope. In the
exemplary clipping device, the outer sheath may have an ID of
approximately 0.088 inches and an OD of about 0.102 inches. The
overall length of the clipping device may be approximately 160
inches, while the tissue grasping portion of the clip arms 208 may
be approximately 0.4 inches long.
[0092] In treating internal bleeding, and in particular to apply an
hemostatic treatment to gastrointestinal bleeding, it is often
necessary to apply more than one hemostatic clip to the injured
tissue. Using conventional methods, the treatment involves
repeatedly utilizing a single deployment clip apparatus, with the
disadvantage of having to remove the old clipping device from the
endoscope, prepare additional clipping devices, and re-inserting
the additional clipping devices in the endoscope for each clip.
After insertion in the endoscope, each additional device has to be
re-positioned over the wounded tissue before the new clip may be
deployed. Multi deployment clipping devices are also in use, but
generally require the device to be removed from the endoscope so
that a new clip may be loaded manually in the device.
[0093] In a further embodiment of the present invention, a
multiclip endoscopic hemostatic device may be used to discharge
multiple hemostatic clips without the necessity to remove the
device from the endoscope after each clip is deployed. The
multiclip device achieves equal or better results than conventional
single deployment clipping devices, while greatly facilitating the
placement of multiple hemostatic clips in cases where a single
hemostatic clip is insufficient. In one embodiment, the clips used
by the multiclip device according to the present invention are
substantially similar in size to conventional hemostatic clips, and
thus can be used with conventional endoscopes. According to the
invention, the cost of manufacturing the multiclip apparatus is
sufficiently low to permit the units to be disposable, and be
discarded after use with only one patient.
[0094] According to the invention, the multiclip hemostatic
clipping apparatus is used in a minimally invasive environment,
such that it is applied to the surgical site through an endoscope.
The distal end of the hemostatic multiclip device is inserted
through the working lumen of the endoscope, and is brought in the
vicinity of the surgical site where the bleeding occurs. For
example, an endoscope having a working channel of at least about
1.8 mm inner diameter may be used to reach the surgical site. The
proximal ends of the endoscope and of the hemostatic multiclip
device are provided with hand controls used by the user/physician
to operate the devices.
[0095] The hemostatic multiclip device according to an exemplary
embodiment of the present invention uses a magazine containing a
plurality of hemostatic clips that is advanced through the
endoscope's working lumen, to a location near the surgical site.
The magazine may be attached to a sheath designed to protect the
inner surfaces of the endoscope from damage caused by sharp edges
of the magazine and clip assembly, and which extends beyond the
magazine through the length of the endoscope. The hemostatic clips
are joined in a clip chain which is inserted in the magazine, and
is free to translate in the magazine within certain limits that
will be described below. Each of the clips may be formed, for
example, of sheet metal or of another material having appropriate
mechanical and bio-compatibility properties. The material of the
clips is selected to resist plastic deformation while constrained
in the closed configuration, so that the hemostatic clips will
return to the open configuration when not otherwise restrained.
[0096] A modified version of the clipping device 100, shown in
FIGS. 1 and 2, may be used with the clip magazine and clip chain
described above. A clip magazine containing multiple hemostatic
clips may be inserted in the proximal end of the shaft section 104,
such that the clips are deployed from the distal end thereof. A
handle 108 and sliding spool 110, or similar implements, may be
used in conjunction with a control linkage to operate the multiclip
dispensing apparatus, as will be described in detail below.
[0097] FIG. 31 shows an exemplary embodiment of a hemostatic clip
according to the present invention. Exemplary clip 702 comprises
two clip arms 704 which have inner facing surfaces adapted to grasp
and retain tissue therebetween when placed in a closed
configuration. In FIG. 31, the clip arms 704 are in the open
configuration which is assumed by the clip 702 in the early phase
of deployment, before the tissue is clamped. Clip 702 may be formed
of two parts joined at the common portion 705, or may be of a
single piece construction. In the exemplary embodiment, clip 702 is
biased in the open configuration (shown in FIG. 31) prior to being
loaded in the clip magazine. A sliding lock ring 706 may be used to
lock clip arms 704 in the closed configuration, which is assumed by
the clip 702 when it is clamped to the tissue. In different
exemplary embodiments, the sliding locking ring 706 may be replaced
by different devices adapted to lock clip arms 704 in the closed
configuration.
[0098] As indicated above, a plurality of clips may be loaded in
the magazine for use with the hemostatic multiclip device according
to the present invention. FIG. 32 shows an exemplary embodiment of
a clip chain according to the invention. Clip chain 700 is formed
by joining hemostatic clips 702 to one another using, for example,
a linking feature 708. Linking feature 708 may comprise an
attachment which retains the two joined clips 702 together as long
as there is no movement of the joined clip ends in a direction
perpendicular to the longitudinal axis of the clips. In this
manner, the clip chain 700 remains intact as long as the clips are
translated in a direction generally along the longitudinal axis of
the clips. One clip may be released, however, by moving the
appropriate clip end along a diameter of the device, that is in a
direction perpendicular to the longitudinal axis. For example,
linking feature 708 may be clamped between the distal ends of clip
arms 704 which are held in the closed configuration. Linking
feature 708 may be formed integrally with the body of hemostatic
clip 702, or may be an optional addition that may be attached to
more conventional clips.
[0099] An exemplary clip magazine 720 is shown in perspective view
in FIG. 36. Clip chain 700 (shown in perspective view in FIG. 35)
may be inserted longitudinally in the hollow channel 722 of
magazine 720, as shown in FIG. 38. Magazine 720 may be a generally
cylindrical structure located at the distal end of the hemostatic
multiclip device, which contains a portion or all of the clips 702
within the clip chain 700. Magazine 720, together with clip chain
700, forms a capsule having dimensions and sufficient flexibility
to comply with the curvature of the endoscope's working channel.
Compliance features 723 may be used to impart flexibility to the
body of magazine 720, and for example may comprise circumferential
slits. A control link 726 may enter a proximal opening 722 of the
clip magazine 720, opposite from the distal end 724.
[0100] The most proximal of the clips 702 may be connected to
control link 726 in a releasable manner. Control link 726 may be
designed to carry compression and tension loads, so that clip chain
700 may be translated in both directions through forces transmitted
by control link 726. Control link 726 may be formed by a rigid
tube, a semi rigid wire, or by any other structural element capable
of transmitting tension and compression loads along the length of
the hemostatic multiclip device. Control link 726 may be connected
to a control handle at the proximal end, to give to the surgeon
control of the clip's deployment.
[0101] FIG. 30 shows a detail of the connection between the control
link 726 and the most proximal hemostatic clip 702. In this
embodiment, control link 726 is a rod or tube which terminates in a
connector portion 727 adapted to push against linking element 708.
Connector portion 727 may also be designed to apply a tension force
to the linking element 708, in a known manner. A sheath 725 may be
used to encapsulate control link 726, to protect the working
channel of an endoscope from damage, and to reduce friction between
the moving control link 726 and the clip magazine 720.
[0102] A control handle portion of the hemostatic multiclip device
(not shown) is provided at the proximal end of the device,
extending outside of the proximal end of the endoscope. The control
portion may be similar to that shown in FIG. 1, and may comprise
hand controls which operate the control link 726 to cause the
deployment and the release of the successive clips 702. For
example, hand movements of the surgeon may be transformed within
the control portion into longitudinal movements of the control link
726 along the working channel of the endoscope. In an exemplary
embodiment, clip chain 700 is rigid in compression and supports
tensile loads, at least while contained within the clip magazine
720. Clip chain 700 can therefore be translated along magazine 720
via movement of the control link 726.
[0103] As shown in FIG. 38, the clip chain 700 is formed of
hemostatic clips 702 which remain attached to one another while
they are within the cylindrical containment of the clip magazine
720. Clip magazine 720 supports and constrains the clips 702 of the
clip chain 700 in the radial direction through a large portion of
its length. This prevents pairs of adjacent clips 702 from
disconnecting, by not allowing relative radial movement between two
clips. In particular, the radial movement of the substantially
closed clip arms 704 of a first hemostatic clip is prevented, so
that the linking feature 708 of a second clip, adjacent to the
first clip, is not released. The exemplary design of clip chain 700
helps to minimize the width of the device, since it is only as wide
as the width of the clips themselves.
[0104] The diameter of clip chain 700 works in conjunction with the
shape of the distal end 724 of clip magazine 720 to control the
position of the distal portion of clip chain 700 through the distal
end 724. As shown in FIG. 37, magazine 720 has a reduced cross
section portion 730 designed to limit the diameter of what passes
therethrough. Specifically, reduced cross section 730 allows the
passage of a single clip unattached to another clip at its distal
end. However, reduced cross section 730 does not allow passage of a
pair of connected clips. This is because the diameter of two
connected clips is greater than the diameter of a single clip. In
the exemplary embodiment that is due to the clip arms 704 not
closing fully when they lock unto the linking feature 708 of
another clip 702, resulting in a greater distal tip diameter of the
clip.
[0105] The function of the clip chain 700 is better shown in FIGS.
39, 40, where a clip 702' is placed to lead the clip chain 700
through the distal end 724 and through cross section reduction 730.
As the control element 726 is pushed distally, clip chain 700 is
pushed distally until its second most distal clip 702 is stopped by
reduced cross section 730, at a position where the most distal clip
702' is outside of magazine 720, and is biased in the open
configuration ready to grasp the tissue. In FIG. 39, the most
distal hemostatic clip 702' is being pushed outside of clip
magazine 720, past the distal end 724. As the control link 726
continues to push distally, clip arms 704 of the second most distal
clip 702 of chain 700 abut the reduced cross section 730 (FIG. 40).
At this point the single distal clip 702' is largely outside of
magazine 720, and its clip arms 704' take the open configuration
since they are no longer constrained by magazine 720.
[0106] Once the user has placed the open clip 702' over the desired
location on the tissue, control link 726 is pulled proximally, so
that clip chain 700 (including the most distal clip 702') is pulled
back into magazine 720, as shown in FIG. 41. Clip sliding lock ring
706 is held distally by lock ring anti-pull back tabs 734, as
distal clip 702' is pulled proximally. This causes lock ring 706 to
move partially over clip arms 704' and lock them in the closed
configuration, to firmly grasp the tissue held within clips arms
704'. At this point the most distal hemostatic clip 702' is clamped
securely over the tissue, but is still attached via linking feature
708 to the clip chain 700.
[0107] After deployment and clamping of the most distal hemostatic
clip 702' is achieved, further proximal movement of the control
linkage 726 causes separation of clip 702' from clip chain 700.
Additional features may be formed on the clip 702' or on the lock
ring 706 to cooperate with distal end 724 and prevent further
proximal movement of the distal clip 702' relative to magazine 720.
The pull back distance of distal clip 702' may be controlled, for
example by properly positioning the additional feature 733, so that
the link between the most distal clip 702' and the next to most
distal clip 702 is located in a relief portion 732 of the distal
end 724. Relief portion 732 may be a movable tab or opening which
allows local diametrical expansion of the clips within that portion
of magazine 720.
[0108] As continued proximal tension force is applied by control
link 726, clip arms 704 of the second most distal clip 702 are
pushed diametrically outward over the interlock feature 708 of the
most distal hemostatic clip 702', which now acts as a cam surface.
Relief portion 732 of the clip magazine 720 allows the outward
expansion due to the outward movement of clip arms 704 over linking
feature 708, thereby permitting clip arms 704 to continue moving
proximally and separate from distal-most clip 702'. In other words,
the separation of the two adjacent clips is caused by the force in
the diametrical direction resulting from clip arms 704 being forced
over clip lock feature 708 of distal clip 702', and this force
overcoming the bias of relief portion 732. Distal most clip 702' is
still prevented to further move proximally by the additional
feature 733 described above, but is now free to move distally and
exit magazine 720.
[0109] FIG. 42 depicts the situation where the "former" most distal
hemostatic clip 702' has been ejected from clip magazine 720, and
is clamped securely to the target tissue. A "new" most distal
hemostatic clip 702 has been pushed partially out of magazine 720,
and its clip arms 704 are in the open configuration, outside of
distal portion 724. The new most distal clip 702 is still connected
to another clip 702 which is fully inside of clip magazine 720, and
is part of clip chain 700. The user may at this point position open
clip arms 704 over the desired tissue, and repeat the process
described above to clamp clip arms 704 over the tissue, lock them
closed, and release the new distal-most clip 702 from the clip
chain 700 and from clip magazine 720.
[0110] To release the most distal clip 702' from the clip chain
700, the clip arms 704 belonging to the clip 702, adjacent to the
clip 702', have to disengage from the linking feature 708'. To do
so, the distal tip of clip arms 704 has to open at least
sufficiently to clear the linking feature 708' of the most distal
clip 702'. The clip 702 is contained within the magazine 720, which
because of its radially rigid construction, for the most part
prevents the clip arms 704 from opening. The only time that the
clip arms 704 can open and release the linking feature 708' is when
the distal tips 705 of the clip arms 704 are substantially aligned
with a section of the magazine 720 which either is radially wider,
or is designed to yield when pressed by the clip arms 704. For
example, the relief portion 732 may comprise a cut out opening or a
non-rigid portion of the magazine's wall, dimensioned to
accommodate the tips 705 of the clip arms 704.
[0111] The utility of the multi clip deployment device according to
the invention may be increased by configuring the multi-clip
magazine so that the release of the linking feature 708' from clip
arms 704 can be performed more easily. In an additional exemplary
embodiment shown in FIG. 43, the magazine 800 is formed with an
expanded section 804 which extends 360 degrees around the
circumference of the magazine 800. The expanded section 804 formed
by the wall of the magazine 800 defines an expanded chamber 810
within the lumen of magazine 800. The expanded chamber 810 provides
for sufficient room within the magazine 800 to allow distal tips
705 of the clip arms 704 to move radially outwards, as the clip
arms 704 open to pass over the linking feature 708'.
[0112] The deployment of the most distal clip 702' from the
exemplary magazine 800 is in many respects similar to the
deployment from the magazine 720, described above. A control link
726 may be used to transfer commands from the surgeon to the clip
deployment mechanism in the form of proximal and distal translation
of the link 726. The most distal clip 702' is initially connected
to a clip chain 700, and may be translated forward and backwards
while still connected to the adjacent clip 702. After the surgeon
places the distal end of clip 702' in position over the target
tissue 822, the most distal clip 702' is pulled back inside the
magazine 800, so that clip arms 704' close over a portion 820 of
the target tissue 822. The lock ring 706' may be pushed distally by
distal lip 806 of the magazine 800, to lock the clip arms 704' in
the closed position around the target tissue portion 820.
[0113] After the most distal clip 702' is clamped and locked in the
closed position around the portion of target tissue 820, further
proximal movement of the clip 702 causes the distal clip 702' and
its adjacent clip 702 to detach. For the purposes of this
discussion, clip 702 is referred to as the next-to-most distal
clip. More specifically. The distal ends 705 of the adjacent clip's
arms 704 partially open to pass over the linking feature 708' of
the most distal clip 702', under the traction applied by the
control linkage 726 which pulls clip 702 proximally. As described
above, the most distal clip 702' is prevented from moving
proximally by the shape of the distal end 806 of the magazine 800,
so that a tension exists between the most distal clip 702' and the
next-to-most distal clip 702. As the clip 702 moves proximally,
linking feature 708' acts as a cam forcing the clip arms 704 to
open. The expanded chamber 810 allows the radial opening of the
clip arms 704, which releases the linking feature 708'.
[0114] The magazine 800 provides several benefits to the multi-clip
deployment device according to the present invention. Since the
expanded section 804 is a radial bulge which spans 360 degrees
around the circumference of the magazine 800, the rotational
orientation of the clip chain 700, which includes clips 702 and
702', within the magazine 800 is not important. The surgeon
therefore has greater liberty to orient the distal clip 702' as
necessary to best perform the procedure. The rotational orientation
of the clip chain 700 may be changed relative to the orientation of
the magazine 800 and of the entire multi-clip delivery device to
which the magazine 800 is attached, to better align the clip with
the target tissue. This configuration simplifies the clip
deployment procedure and makes the entire procedure simpler and
less time consuming. In addition, manufacturing of the magazine 800
can be simpler, since there is no need to process the magazine to
form radial relief regions such as relief portions 732, or to cut
openings in the wall of the magazine 800.
[0115] An exemplary clip deployment sequence from a magazine 800
according to the present invention is described below. FIGS. 44-48
are used to depict the deployment of a most distal clip 702' from
the magazine 800. FIG. 44 depicts a pre-deployment configuration of
the most distal clip 702' from the magazine 800, such that the clip
arms 704' are completely within the distal portion 802 of the
magazine 800. In this configuration, the linking feature 708' is
being grasped by the clip arms 704 of the clip 702, such that the
two clips 702, 702' are connected in the clip chain 700. The lock
ring 706' is away from the clip arms 704', and does not yet
constrain them in the closed configuration. In this step of the
deployment, the surgeon may position the distal tip 802 of the
magazine 800 in proximity of the target tissue, while preparing to
clamp the clip 702' to that tissue.
[0116] As the control link 726 is pushed distally during a distal
stroke of the deployment sequence, clip 702' is pushed outside of
the magazine 800, as shown in FIG. 45. In this configuration, the
arms 704' of clip 702' are no longer constrained by the walls of
the magazine 800. The lock ring 706' is still near the clip's
proximal end, held by the tip 802 within the magazine 800, so that
the clip arms 704' are free to move to the open configuration. At
this point, the clips 702, 702' are connected by means of the
linking feature 708', and are free to rotate 360 degrees in any
rotational orientation within the magazine 800 to facilitate proper
orientation relative to the tissue to be clamped. Using the ability
to place the clip 702' in any desired rotational orientation, the
surgeon can orient the clip arms 704' in any desired position over
the target tissue 820, so that closing the clip arms causes the
tissue to be clamped as effectively as possible.
[0117] When the clip arms 704' are correctly placed in the proper
orientation over the target tissue 820, the surgeon may continue
the deployment by carrying out a proximal stroke of the deployment
sequence. This causes the control link 726 to move proximally, thus
entraining clip 704 and clip 704'. As described in the context of
other embodiments, the proximal stroke of control link 726 causes
the clip arms 704' to close, and clamp on the portion 820 of the
target tissue 822. Distal end 802 of the magazine 800 forces the
clip arms 704' to close as clip 702' moves proximally inside of the
magazine 800, such that the target tissue is clamped, as shown in
FIG. 46. The lock ring 706' is held near distal tip 802 by
protrusions within magazine 800, and slides distally over the clip
arms 704' as they are pulled proximally within the magazine 800. In
this manner, the clip arms 704' are securely locked in the closed
configuration by ring 706', and are clamped on the target tissue.
After the clip arms 704' are locked in the closed configuration on
the target tissue, the magazine 800 and the rest of the device can
be rotated relative to the clips 702, 702', since these are free to
turn 360 degrees within the magazine 800.
[0118] Continued proximal tension on the control link 726 causes
the clip 702 to further move proximally within the magazine 800.
FIG. 47 depicts this step of the clip deployment process. However,
the most distal clip 702' is prevented from further proximal
movement by the lock ring 706' interacting with the protrusions
formed at the distal end 802 of the magazine 800. Lock ring 706' is
also prevented from moving too far distally over the closed clip
arms 704' by ring stops 705. Accordingly, clip arms 704 are pushed
apart by the linking feature 708, which acts as a cam as the tip of
clip arms 704 pass over it. The expanded chamber 810 defined by the
expanded section 804 of magazine 800 gives sufficient room to the
clip legs 704 to open and pass over the linking element 708', so
that the clip 702 can disengage from the clip 702'. Expanded
section 804 extends 360 degrees around the circumference of the
magazine 800, so that the orientation of clips 702, 702' within the
magazine 800 is not important. This makes it possible for the
surgeon to change the rotational orientation of the clip 702'
relative to the magazine 800 throughout the deployment steps, to
maintain the desired orientation between the clip 702' and the
target tissue 822.
[0119] FIG. 48 depicts the final step of the clip deployment
sequence, in which the clip 702' is released from the magazine 800
and is left clamped to the target tissue. In this step, control
link 726 may be again moved distally, to push clips 702 and 702',
which are now disconnected. As shown, clip 702' is pushed outside
of the magazine 800 by the distal portion of clip 702, until it is
ejected from the magazine 800. Clip 702 now becomes the most distal
clip present in the magazine 800, and the same steps described
relative to carry out the deployment of clip 702' may be repeated
to deploy the new clip 702. Although the drawings depict a magazine
800 containing only two clips 702 and 702', it will be apparent to
those of skill in the art that additional clips may be connected in
the same manner within magazine 800, to form a longer clip chain
700.
[0120] As described, the distal most clip 702' after release from
the clip chain 700, or more simply from clip 702, may exit clip
magazine 800 due to the tension applied to it by the clamped
tissue. Alternatively, clip 702' may be pushed out by the distal
movement of clip 702, as it is pushed towards the distal end 802.
The surgeon may ensure a complete release of clip 702' by causing
the control link 726 to move distally, for example by manipulating
the hand control of the device. Conventional methods may be used to
transform the hand movements of the surgeon into translation of the
control link 726, and to carry out the initial distal stroke and
the subsequent proximal stroke.
[0121] The present invention has been described with reference to
specific exemplary embodiments. Those skilled in the art will
understand that changes may be made in details, particularly in
matters of shape, size, material and arrangement of parts without
departing from the teaching of the invention. Accordingly, various
modifications and changes may be made to the embodiments without
departing from the broadest scope of the invention as set forth in
the claims that follow. The specifications and drawings are,
therefore, to be regarded in an illustrative rather than a
restrictive sense.
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